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TAMPA — HedgePath Pharmaceuticals Inc. has started enrolling patients for a clinical trial for a potential cancer treatment.
The Phase II(b) trial will measure the safety and effectiveness of giving twice-daily doses of oral capsules of the antifungal drug SUBA-Itraconazole. The drug will be used to treat the most common form of skin cancer growths or sores, basal cell carcinoma, in patients with a rare genetic disorder that makes them more susceptible to various cancers, called basal cell carcinoma nevus syndrome.
The clinical trial will look at up to 40 patients in three locations in the United States. The study, according to a press release, will be considered a success if the drug can cause a 30% or greater reduction in the overall size of a patient's target tumors.
There are about 10,000 patients in the United States with basal cell carcinoma nevus syndrome, which could potentially qualify the drug treatment under the FDA's Orphan Drug Designation Program, the release adds.
Tampa-based HedgePath expects to be able to gauge initial results of the trial in the first quarter next year.
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